PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A for Pneumococcal disease

Inclusion criteria

• {"criterion_text":"- Aged 7 months to 17 years on the day of inclusion\n- Participants who are healthy as determined by medical evaluation including medical history and physical examination\n- For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only : Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight 1.5 kg, and in both cases medically stable as assessed by the investigator\n- For adolescents (6 to 17 YoA) only : A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: ls of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.\n- Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations\n- Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures"}

Exclusion criteria

• {"criterion_text":"- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti­ cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy\n- For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : previous vaccination with pneumococcal polysaccharide vaccine\n- For adolescents (6 to 17 YoA) only : Alcohol, prescription drug, or substance abuse that, in the opinion of the lnvestigator, might interfere with the study conduct or completion\n- Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations\n- Receipt of immune globulins, blood or blood-derived products in the past 3 months\n- For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw\n- Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure\n- For adolescents (6 to 17 YoA) only •\tDeprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily •\tldentified as an lnvestigator or employee of the lnvestigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted chiId) of the lnvestigator or employee with direct involvement in the proposed study\n- History of microbiologically confirmed S. pneumoniae infection or disease\n- History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy\n- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances\n- Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / LAR(s), contraindicating intramuscular (IM) injection\n- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection\n- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature\t38.0°C [100.4°F]) on the day of vaccine administration.\n- For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only :\tPrevious vaccination against S. pneumonia"}

Primary endpoints

• {"endpoint_text":"- Number of participants reporting immediate adverse events (AEs)","definition_or_measurement_approach":"Count of participants reporting immediate adverse events following vaccination as collected by study safety assessments and AE reporting procedures."}
• {"endpoint_text":"- Number of participants reporting solicited injection site and solicited systemic reactions","definition_or_measurement_approach":"Count of participants reporting prespecified (solicited) local injection-site and systemic reactions captured by solicited safety diary/reports."}
• {"endpoint_text":"- Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after each and any injection of a pneumococcal vaccine","definition_or_measurement_approach":"Count of participants reporting unsolicited local or systemic adverse events collected after each vaccine injection (spontaneous AE reporting)."}
• {"endpoint_text":"- Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)","definition_or_measurement_approach":"Count of participants with SAEs and AESIs as defined by the protocol safety definitions and reported through standard SAE/AESI reporting procedures."}
• {"endpoint_text":"- Number of Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): with serotype-specific lgG concentrations for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific IgG concentrations measured for all PCV21 serotypes; immunogenicity assessed (per objectives) at 30 days after the last dose, with geometric mean concentration (GMC) summaries."}
• {"endpoint_text":"- Number of Children (2-5 years of age [YoA]):with serotype specific OPA titers for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific opsonophagocytic activity (OPA) titers measured for all PCV21 serotypes at 30 days post-dose."}
• {"endpoint_text":"- Number of Children (2-5 years of age [YoA]):with serotype specific lgG concentrations for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific IgG concentrations measured for all PCV21 serotypes at 30 days post-dose; assessed by GMC."}
• {"endpoint_text":"- Number of Children/adolescents (6-17 YoA):with serotype specific OPA titers for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific OPA titers measured for all PCV21 serotypes at 30 days post-dose."}

Secondary endpoints

• {"endpoint_text":"- Number of Children/adolescents (≥2 YoA) with serotype specific OPA titers for all serotypes included in PCV 21","definition_or_measurement_approach":"Serotype-specific OPA titers for participants ≥2 years, measured at 30 days post-dose; comparisons for non-inferiority by GMT."}
• {"endpoint_text":"- Number of Children/adolescents (≥2 YoA): with serotype specific lgG concentrations for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific IgG concentrations for participants ≥2 years, measured at 30 days post-dose; assessed by GMC for non-inferiority comparisons."}
• {"endpoint_text":"- Number of participants (all age groups) with serotype specific lgG concentration ≥ 0.35 µg/ml for all serotypes included in PCV21","definition_or_measurement_approach":"Number/percentage of participants achieving serotype-specific IgG concentration ≥0.35 µg/ml for all PCV21 serotypes (measured at 30 days post-dose)."}
• {"endpoint_text":"- Number of infants (7-11 MoA) and toddlers(12-23 MoA):with serotype specific OPA titers for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific OPA titers for infants and toddlers measured at 30 days after last dose."}
• {"endpoint_text":"- Percentage of infants (7-11 MoA) and toddlers(12-23 MoA): with serotype specific OPA titers ≥ LLOQ for all serotypes included in PCV21","definition_or_measurement_approach":"Percentage of infants and toddlers with OPA titers ≥ lower limit of quantification (LLOQ) for all PCV21 serotypes at 30 days post-dose."}
• {"endpoint_text":"- Number of Children/adolescents (6-17 YoA):with serotype specific lgG concentrations for all serotypes included in PCV21","definition_or_measurement_approach":"Serotype-specific IgG concentrations for children/adolescents 6-17 years measured at 30 days post-dose; reported as GMC."}

Methods

• Recruitment arrangements document (K1) — country-specific recruitment arrangements (documents listed for Estonia and Poland)
• Local advertisements (K2_..._Advertisement_MediTrials-OU_EE) — Estonia (Estonian and Russian versions available)
• Doctor-to-Patient letters (K2) — Estonia and Poland (documents listed)
• Doctor-to-Doctor letters (K2) — Poland (document listed)
• Patient flyers and brochures (K2, Pneumococcal_Brochure, Patient-Flyer) — Estonia and Poland (documents listed)
• Site-based recruitment via participating clinics and trial centres (site list provided for Estonia and Poland)

Estonia

Earliest CTIS Part Ii Submission Date

03-03-2025

Latest Decision Or Authorization Date

03-10-2025

Processing Time Days

214

Number Of Sites

7

Number Of Participants

400

Poland

Earliest CTIS Part Ii Submission Date

28-02-2025

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

264

Number Of Sites

8

Number Of Participants

310

Primary sponsor

Full Name

Sanofi Pasteur Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Fisher Clinical Services Inc.

Responsibilities

14

Name

PPD Global Limited

Responsibilities

4

Name

PPD Development LP

Responsibilities

1,10,11,12,14,15,2,3,5,6,7,8

Third parties

• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"1,10,11,12,14,15,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"P95","duties_or_roles":"11","organisation_type":"Pharmaceutical company"}